Are We Ready for Designer Babies? Analysis of Law, Policy and Ethics Surrounding Germline Genetic Engineering

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Are we ready for Designer Babies? Analysis of law, policy and ethics surrounding germline genetic engineering

Strategic, Legal, Tax and Ethical issues

June 2019

Analysis of law, policy and ethics surrounding germline genetic engineering

Strategic, Legal, Tax and Ethical Issues

June 2019

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DMS Code: No 480049v2

Analysis of law, policy and ethics surrounding germline genetic engineering About NDA

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Analysis of law, policy and ethics surrounding germline genetic engineering

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Acknowledgements

Dr. Milind Antani [email protected]

Darren Punnen [email protected]

With genetic engineering, we will be able to increase the complexity of our DNA, and improve the human race. But it will be a slow process, because one will have to wait about 18 years to see the effect of changes to the genetic code – Stephen Hawking

Transhumanism is the ethics and science of using things like biological and genetic engineering to transform our bodies and make us a more powerful species. – Dan Brown

I don’t think we are going to see superman or a split in the species any time soon, because we just don’t know enough – Henry Greely, bioethicist

I see nothing wrong ethically with the idea of correcting single gene defects through genetic engineering. But I am concerned about any other kind of intervention, for anything else would be an experiment, which would impose our will on future generations and take unreasonable chances with their welfare ... Thus, such intervention is beyond the scope of consideration. – Ian Wilmut in The Second Creation: Dolly and the Age of Biological Control

Oh, happy day, when miracles take place And scientists control the human race, When we assume authority of human chromosomes, And assembly-line women, Conveyor-belt men Settle down in push-button homes.– Li’l Abner, “Oh, Happy Day”

How could you do something like that? That’s horrible, going around altering the genetics of babies! How could you do that to my parents? – Children of an Elder God

The cloning of humans is on most of the lists of things to worry about from Science, along with behaviour control, genetic engineering, transplanted heads, computer poetry and the unrestrained growth of plastic flowers. – Lewis Thomas

Analysis of law, policy and ethics surrounding germline genetic engineering

Genetic engineering has never been about saving the world, it’s about controlling the world. – Vandana Shiva

India has the opportunity to be a leader in genetic engineering, It has institutions that no other country has. – Nina Fedoroff

It is difficult to imagine a greater imposition than adding genes to future generations that changes the nature of future people. – Ian Wilmut

The time to talk about it [genetic engineering to improve a baby’s genes] in schools and churches and magazines and debate societies is now. If you wait, five years from now the gene doctor will be hanging out the MAKE A SMARTER BABY sign down the street. – Arthur Caplan

I suspect any worries about genetic engineering may be unnecessary. Genetic mutations have always happened naturally, anyway. – James Lovelock

Genetic engineering is a result of science advancement, so I don’t think that in itself is bad. If used wisely, genetics can be beneficial, but they can be abused, too. – Hideo Kojima

Right now people are interested in genetic engineering to help the human race. That’s a noble cause, and that’s where we should be heading. But once we get past that - once we understand what genetic diseases we can deal with - when we start thinking about the future, there’s an opportunity to create some new life-forms. – Jack Horner

Analysis of law, policy and ethics surrounding germline genetic engineering Contents

1. EXECUTIVE SUMMARY 01

2. INTRODUCTION 02

I. Important concepts 02

3. LEGAL AND REGULATORY FRAMEWORK WITH ANALYSIS 05

I. India 05 II. USA 05 III. UK 06 IV. China 07 V. Japan 07 VI. Other Important Jurisdictions 08

4. RECENT MEDICAL AND TECHNOLOGICAL ADVANCES 09

5. ETHICAL ISSUES 10

6. INTELLECTUAL PROPERTY RIGHT ISSUE 12

7. LIMITATIONS AND CHALLENGES IN INDIA 14

8. THE PRESENT AND FUTURE OF DESIGNER BABIES IN INDIA – A CLARION CALL FOR CHANGE 15

9. DESIGNING THE LAW ON DESIGNER BABIES 16

10. CONCLUSION 17

OUR EXPERTISE IN PHARMACEUTICAL AND HEALTHCARE 18

I. Introduction 18 II. Services 18

Analysis of law, policy and ethics surrounding germline genetic engineering 1. Executive summary

Genetic Engineering is poised to create research into this unknown but welcome a revolution that may lead to significant field. It definitely brings to light certain social, ethical and legal issues considering its impact ethical and religious concerns surrounding on human lives and possibly value system. genetic editing which could be passed from It is likely to make more severe impact, one generation to the other. The policies and if it is practiced in India. guidelines framed by many countries with respect to gene editing are failing to keep up Genetic engineering or gene editing, in simple with the speed of advancement made in the field. terms, is the direct manipulation of an organism’s genes, to alter an organism’s characteristics in In this research paper, we have analyzed the a particular way. While this technology has been legal and regulatory framework applicable to known to scientists for a long time, it is the rapid germ line gene editing, with specific emphasis development of this technology, through germ on its application to produce designer babies. line gene editing, more specifically through We have also analyzed some of the pressing the CRISPR-Cas9 technique, which has taken ethical and social issues that surface in context over the world by storm. With the capacity to of producing designer babies. A comparative alter the genes of a human embryo, potentially analysis of the legal position on germ line gene removing all the genetic defects and introducing editing adopted by USA, UK, China and Japan new characteristics, germ line gene editing is has also been undertaken. The paper concludes ushering in a brave new world. This brings to the with legal recommendations for regulation of focus the capability or in some cases, incapability germ line gene editing in India. of national and international law to regulate

2. Introduction

The Oxford Dictionary1 defines “designer baby” has a different effect (for example, to replace as “a baby whose genetic makeup has been a disease-causing variant with a non-disease selected in order to eradicate a particular defect, variant). The edited DNA would then become or to ensure that a particular gene is present.” part of the genome of the growing embryo so that any future person resulting from that A designer baby could, in theory, be free from embryo, sperm, or egg would have that variant genetic diseases such as haemophilia, cystic in all their cells.4 Therefore, it is not surprising fibrosis or muscular dystrophy and many such that human germline modification has for diseases. The designer baby could also have many years been widely considered off-limits, traits and characteristics considered as preferred for both safety and social reasons. It is formally traits, such as height, eye color, musicality, prohibited in more than 40 countries.5 intelligence etc. While the idea of a designer baby has till now I. Important concepts been a far-fetched dream, it appears that it could now become a reality. A scientist in China has Before diving into the law and ethics behind reportedly already modified the germline of live germ line genetic editing (which could lead fetuses to make them HIV-free by genetic design. to creation of designer babies), it is important The twin girls whose genes were modified have to understand some of the scientific terms already taken birth and a third such baby is on frequently used in this research paper. the way.2 A designer baby, therefore, may be a reality soon, made possible by human germline a. Gene: A gene is the basic physical and editing in India as well. functional unit of heredity that is present in all cells. Genes are made up of DNA.6 However, the definition of “designer baby” does not fully indicate the consequences of b. DNA: DNA, or deoxyribonucleic acid, is creating a designer baby and hence they need a molecule that carries the hereditary to be discussed and understood. Germline material in humans and almost all other editing, used in the creation of designer babies, organisms. Over 99% of DNA is same in all is a form of genetic modification that involves people.7 The DNA in our genes contains changing genes in eggs, sperm, or very early the ‘code’ which is read by each and every embryos. This type of genome modification cell of the body in order to understand its is heritable, meaning that the modified genes expression i.e. its role and function in the could appear not only in the offspring that body. It is the code stored in our genes result from the procedure, but also in the that define our physical makeup such as subsequent generations.3 Heritable genome heights, skin or hair color and may also editing interventions are not currently available influence certain behavioral traits. as a reproductive option, but they could be in the future. The aim of heritable genome editing would be to edit a sequence of Deoxyribonucleic acid (“DNA”) in an embryo, sperm, or egg, in 4. Nuffield Council on Bio ethics, Genome editing and human reproduction: social and ethical issues short guide, http:// order to replace a variant of a gene that has one nuffieldbioethics.org/wp-content/uploads/Genome-editing- kind of effect with another known variant that and-human-reproduction-short-guide-website.pdf (last accessed on Sep. 8, 2018) 5. Center for Genetics and Society, About Human Germline Gene Editing, https://www.geneticsandsociety.org/internal- 1. Oxford English Dictionary Twelfth Edition, 2011 content/about-human-germline-gene-editing (last accessed on Sep. 8, 2018) 2. https://www.technologyreview.com/s/612458/exclusive- chinese-scientists-are-creating-crispr-babies/ 6. https://ghr.nlm.nih.gov/primer/basics/gene 3. National Guidelines for Stem Cell Research 2017, Glossary. 7. https://ghr.nlm.nih.gov/primer/basics/dna

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Analysis of law, policy and ethics surrounding germline genetic engineering

c. Gamete: A mature male or female i. Gene therapy: A scientific technique reproductive cell usually possessing a for treatment or prevention of disease or haploid set of chromosomes and capable disorder by insertion or removal of a gene. of initiating formation of a new diploid j. ‘Spare’ embryo: An embryo created during individual by fusion with a gamete of the the course of in vitro fertilization (“IVF”) opposite sex i.e. an egg (in the female) treatment of the infertile couple which and a sperm (in the male). A diploid set of is not utilized for the purpose of IVF, also chromosomes is double the haploid number known as supernumerary embryo. of chromosomes in an organism. In humans, the diploid number of chromosomes is 46. k. CRISPR: CRISPR stands for clustered, regularly interspaced, short palindromic d. Germ cell: Ova and sperm, and their repeats. Cas9 stands for CRISPR-associated precursors. protein 9 (Cas9). It is a revolutionary e. Embryo: In humans, it is an early stage technique for germ line gene editing that of development of a multicellular diploid has made gene editing cheaper and more eukaryotic organism from the time of accessible to scientists and laboratories. fertilization of ova until the end of the l. CRISPR-Cas9 technology allows scientist eighth week of gestation, after which it is to cut-and-paste a desired ‘code’ in the gene. known as a fetus. The specific location of the genetic code f. Fetus: In humans, it is the developing that is required to be altered is identified on stage of a multicellular diploid eukaryotic the DNA strand, and then, using the Cas9 organism that follows the embryonic protein, which acts like a pair of scissors, that stage, i.e. from eight weeks post location is cut off from the strand. A DNA fertilization till birth strand, when broken, has a natural tendency to repair itself. Scientists intervene during g. In vitro: Of processes or reactions taking this auto-repair process, supplying the place in a test tube, culture dish, or desired sequence of genetic codes that binds elsewhere outside a living organism. itself with the broken DNA strand.8 h. In vivo: Of processes taking place in a living organism 8. http://www.insightsonindia.com/2018/11/28/crispr-technology/

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Analysis of law, policy and ethics surrounding germline genetic engineering 3. Legal and Regulatory Framework with Analysis

The legal framework in various jurisdictions Research (“IC-SCR”), the Institutional Ethics is diverse, taking into consideration the vast Committee (“IEC”), and the Institutional differences in social, cultural and moral norms. Biosafety Committee (“IBSC”), and the It is nonetheless important to see the legal Review Committee on Genetic Manipulation and regulatory framework in India and other (“RCGM”). In-vitro studies can only be jurisdictions to understand the law and how these conducted on spare embryos, germ-line cells or countries have treated the germ line gene editing- gametes. Further, the genome modified human embryos should not be cultured beyond 14 days I. India of fertilization or formation of the primitive streak, whichever is earlier to ensure that these embryos should not have a possibility of being India does not have any specific law that inserted into the womb.10 explicitly prohibits genetic editing of germ lines. However, the Indian Council of Medical Therefore, any research that may lead to Research (“ICMR”) , a government organization, creation of designer babies is prohibited by published the National Ethical Guidelines for non-mandatory guidelines in India. Biomedical and Health Research on Human Participants (“Ethical Guidelines”), which II. USA prohibited “eugenic genetic engineering for changing/selecting/altering genetic characteristics In the USA, the acceptance of the use of germ and creating so called designer babies…” In line editing has been growing slowly but addition to the Ethical Guidelines, the National steadily. The National Institute of Health Guidelines for Stem Cell Research 2017 (“NIH”), which is a part of the U.S. Department (“Guidelines”) published by the ICMR and of Health and Human Services, published the Department of Biotechnology, Ministry guidelines the, “NIH Guidelines for Research of Science & Technology (“DBT”), provide all Involving Recombinant or Synthetic Nucleic the necessary guidance for cellular research Acid Molecules” in 2016 which stated that the including gene editing or modification, human NIH would not entertain proposals for germ germ-line engineering and reproductive cloning. line alterations, involving a specific attempt The Guidelines prohibit research related to to introduce genetic changes into the human germ line gene therapy in the current reproductive cells of an individual, with the state of scientific knowledge and understanding. aim of changing the set of genes passed on to Research involving implantation of human the individual’s offspring. It did however state embryos (generated by any means) after in vitro that it would consider proposals involving manipulation, at any stage of development, somatic cell gene transfer.11 into uterus in humans or primates is also In 2017 however, the National Academy strictly prohibited.9 of Science (“NAS”), a private not-for-profit To the extent that genome modification is organization which provides advice to the permitted, such modification can only be US Government on matters of science done through in vitro studies (i.e. outside the and technology, published a report titled, human body) and requires thorough review by the Institutional Committee for Stem Cell 10. Clause 8.2. Restrictive Areas of Research of Guidelines 11. NIH Guidelines for Research Involving Recombinant or 9. Clause 8.3 Prohibited Areas of Research of Guidelines Synthetic Nucleic Acid Molecules see Appendix M

“Human Genome Editing Science, Ethics and The Report recommends that germ line editing Governance” (“Report”) which states that research trials might be permitted but should given both the technical and societal concerns, only be done for compelling reasons of treating there is a need for caution in any move towards or preventing serious disease or disabilities germ line editing. However, that caution does and under strict oversight. The committee also not mean prohibition. The Report gave recommended that genome editing for purposes a cautious green light to germ-line editing other than treatment or prevention of disease under certain conditions which include:12 and disability (for example enhancement) should not be conducted, and that it is essential i. absence of reasonable alternatives; for public discussions to precede any decisions ii. restriction to preventing a serious disease about whether or how to pursue clinical trials of or condition; such applications. iii. restriction to editing genes that have On the heels of the conditional green light given been convincingly demonstrated to by the NAS, the researchers in Portland, Oregon cause or strongly predispose to that undertook the gene editing of human embryos, disease or condition; which is explained later. iv. restriction to converting such genes to versions that are prevalent in the III. UK population and are known to be associated with ordinary health with little or The UK has in recent times, been liberal towards no evidence of adverse effects; allowing gene editing after fulfillment of certain conditions. The Human fertilization and v. availability of credible pre-clinical and/or Embryology Act 1990 (“HFEA”) regulates the clinical data on risks and potential health law on research on embryos. The HFEA permits benefits of the procedures; research projects on embryos with a license, vi. during the trial, ongoing, rigorous provided the embryo is not kept for a period oversight of the effects of the procedure of more than 14 days and not transferred into on the health and safety of the research the womb of a woman.13 In 2015 the Human participants; fertilization and Embryology (Mitochondrial Donation) Regulations were passed which vii. comprehensive plans for long-term allowed for germ-line modification of nuclear multigenerational follow-up that still DNA that could be passed on to future respect personal autonomy; generations. However, the government was viii. maximum transparency consistent with firm in its distinction between mitochondrial patient privacy; donation and genetic modification, stating that mitochondrial donation does not affect any ix. continued reassessment of both health genes transmitted through germ line of men and societal benefits and risks, with broad, born through these techniques, but accepted that ongoing participation and input from the it could still be defined as germ line therapy.14 public; and The UK’s approach to germ line gene editing x. reliable oversight mechanisms to prevent has been more open than rest of the world. extension to uses other than preventing It is lawful in the UK to create and use genome a serious disease or condition. edited human embryos, sperm or eggs in

13. Schedule 2 of HFEA 12. NAS, Human Genome Editing Science, Ethics and 14. Department of Health, In Vitro Fertilisation: Written question - Governance http://nationalacademies.org/cs/groups/ HL4366 https://www.parliament.uk/business/publications/ genesite/documents/webpage/gene_177260.pdf (last accessed written-questions-answers-statements/written-question/ on Sep. 8, 2018) Lords/2015-01-22/HL4366/ (last accessed on Sep. 8, 2018)

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Analysis of law, policy and ethics surrounding germline genetic engineering

research, under strict licensing conditions (“HAP Guidelines”) prepared in 2001, by the However, it is still illegal to use gene edited Ministry of Health of the People’s Republic of human embryos in assisted reproduction.15 China lay down certain ethical principles for The authority constituted under HFEA, the human assisted reproductive technologies as Human fertilization and Embryology Authority well as guidelines for practitioners. The HAP granted a license in 2016 to scientists in London Guidelines prohibit the manipulation of the to alter genes that are active in healthy human gene in human gamete, zygote or embryo for embryos in the first few days after fertilization. the purpose of reproduction.17 Therefore, the The researchers could do the experiments only prohibition in gene manipulation is limited to for seven days, after which the embryos were reproduction and does not extend to research. to be destroyed. The genetic modifications Experiments conducted for research purposes could help researchers to develop treatments using embryos which will never develop into for infertility, but will not themselves form the humans are outside the scope of the guidelines basis of a therapy. This approval represents the and are therefore, permitted. Taking advantage world’s first research project on genetic editing of this loophole, Chinese scientists have endorsed by a national regulatory authority.16 reportedly conducted gene editing experiments, which are explained in the next section. The development of acceptance of gene editing in UK has been progressing impressively. In July 2018, the Nuffield Council on Bioethics, the V. Japan ethics body of the U.K., published a report titled “Genome editing and human reproduction: Japan at present, does not have a legal social and ethical issues”, and concluded framework specific to genome editing. However, that the use of genome editing interventions in response to the experiments conducted in to influence the characteristics of future China in 2015, the Japanese Cabinet Office’s generations could be ethically acceptable in Life Ethics Study Group (“LESG”) issued an some circumstances, provided it upholds the interim report in April 2016 accepting basic principals of social justice and solidarity, i.e. it genome editing research on manipulating genes should not be expected to increase disadvantage, in fertilized human embryos but regarded the discrimination, or division in society. It also laid returning of embryo whose problematic gene down that the welfare of the future person, who was modified through genome editing to may be born as a consequence of such genetic a womb as unacceptable.18 The LESG report laid editing procedures, is kept supreme. down that such research on genome editing may be conducted for purposes relating to embryonic Therefore, it is seen the UK laws are more development; treating congenital hard-to-cure expansive and inclusive to allow for research diseases and improving assisted reproductive into “designer babies.” technologies. The report, however cautioned the researchers to limit the research to 14 days of IV. China a human embryo’s development and to dispose of the embryos after research is conducted. In China, there is no legislation regulating The LESG flatly turned down clinical use of genome editing or engineering of human human genome editing at this stage, citing embryos. However, guidelines called the the following risks- “Ethical Principles and Conduct Norms of Human Assisted Reproductive Technologies”

17. Unofficial translation of the Ethical Principles and Conduct 15. Supra note 4, at 3 Norms of Human Assisted Reproductive Technologies.” 16. Ewen Callaway, UK scientists gain licence to edit genes in human https://mrc.ukri.org/publications/browse/china-uk-research- embryos https://www.nature.com/news/uk-scientists-gain- ethics-cure-committee-report/ see page 46 licence-to-edit-genes-in-human-embryos-1.19270 (last 18. http://www.eubios.info/EJAIB112016.pdf (last accessed accessed on Sep. 8, 2018) February 6, 2019).

i. Inaccurate or incomplete editing such as VI. Other Important off-target mutations and mosaicism; Jurisdictions ii. Interminglement of modified and unmodified genes; In Canada, human germline editing is banned. It is criminalized under the 2004 Assisted iii. Difficulty to predict what effects gene Human Reproduction Act (“AHRA”), and alteration; and punishable by fines of 500,000 Canadian dollars iv. Risks that future generations may face as and the possibility of punishable with fine. a result of genetic alterations in embryos AHRA however, lacks a clear regulatory body passed from generation to generation.19 to oversee its implementation.20 Apart from the LESG report, Japan has no law governing research into or clinical use of genome editing.

20. Kathleen M. Vogel, Crispr goes global: A snapshot of rules, 19. Japan Times, Human genome editing, https://www.japantimes. policies, and attitudes https://thebulletin.org/2018/06/crispr- co.jp/opinion/2016/09/26/editorials/human-genome- goes-global-a-snapshot-of-rules-policies-and-attitudes/ (last editing/#article_history (last accessed on Sep. 7 2018) accessed on Sep. 8, 2018)

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Analysis of law, policy and ethics surrounding germline genetic engineering 4. Recent Medical and Technological Advances

In November 2018, it was reported that a scientist ii. The potential of gene editing to cure in China had been carrying out genetic tests out diseases and save lives is evidenced by a on fetuses as late as 24 weeks, and that the world’s recent report of a baby having incurable first genetically edited babies using CRISPR-Cas9 leukemia getting highly experimental, technique, a set of twin girls, have already been genetically edited cells in a tiny 1-millileter born. As a result, the unofficial international intravenous infusion.23 This treatment used moratorium on editing human embryos intended ‘molecular scissors’ to edit genes and create for a pregnancy had been violated. The scientist in designer immune cells programmed to question, has defended his decision to edit genes hunt and kill drug resistant leukaemia. This of the baby girls stating that the objective of his breakthrough came from Great Ormond experiment was to disable a gene called CCR5 so Street Hospital (“GOSH”) and University the girls might be resistant to potential infection College London’sInstitute of Child Health’s with HIV/AIDS. This was important because the (“ICH”) pioneering research teams with father of the girls had HIV and wanted to ensure support from the National Institute for his children would never suffer like he has.21 Health Research (NIHR) Great Ormond Street Biomedical Research Centre.24 Some other notable advances are listed below: iii. In USA, a team of researchers in Portland, i. Chinese scientists at Sun Yat-sen Oregon attempted at creating genetically University in Guangzhou attempted to modified human embryos, by changing the modify the gene which is responsible for DNA of a large number of one-cell embryos Ά-thalassaemia, a potentially fatal blood with the use of gene-editing technique disorder, using CRISPR-Cas9. During the CRISPR. None of the embryos were allowed experiment, 54 embryos which could to develop for more than a few days, but not result in a live birth (nonviable) were CRISPR was injected into the eggs at the genetically tested. Out of the 54 embryos same time they were fertilized with sperm tested only 28 were successfully spliced, in order to avoid the “off target” effect that and that only a fraction of those contained was found in the Chinese experiments.25 the replacement genetic material. While the rates of “off-target” mutations were iv. In India, there has been no reported germ much higher than those observed in gene- line gene editing experiment on human editing studies of mouse embryos or human embryos. This is a marked difference to adult cells,22 this experiment illustrates China, USA and UK, where there have the medical strides that have been taken huge leaps forward towards development by the scientists in attempting to not only of this field. eradicate genetic disease in embryos, but also take positive action towards creating a genetically modified child, who may be

completely illness free. 23. Kate Kelland, Baby With Incurable Leukemia Cured With Designer Immune Cells https://www.huffingtonpost.com/ entry/baby-with-incurable-leukemia-cured-with-designer- immune-cells_us_563bf870e4b0411d3070759a (last accessed on Sep. 8, 2018) 21. https://www.vox.com/science-and-health/2018/11/30/ 18119589/crispr-technology-he-jiankuil; https://www. 24. GOSH, World first use of gene-edited immune cells to treat nytimes.com/2018/11/26/health/gene-editing-babies-china. ‘incurable’ leukaemia https://www.gosh.nhs.uk/news/latest- html; https://www.technologyreview.com/s/612458/ press-releases/2015-press-release-archive/world-first-use-gene- exclusive-chinese-scientists-are-creating-crispr-babies/ edited-immune-cells-treat-incurable-leukaemia (last accessed on Sep. 8, 2018) 22. David Cyranoski and Sara Reardon, Chinese scientists genetically modify human embryos https://www.nature.com/news/chinese- 25. Steve Connor, First Human Embryos Edited in U.S. https://www. scientists-genetically-modify-human-embryos-1.17378?WT. technologyreview.com/s/608350/first-human-embryos- mc_id=TWT_NatureNews (last accessed on Sep. 8, 2018) edited-in-us/?set=608342 (last accessed on Sep. 8, 2018)

5. Ethical Issues

More than legal restrictions, it is the ethical and especially if such research is exploited for social concerns surrounding creation of designer non-therapeutic modifications. Unexpected babies that act as a major roadblock for the science. genetic mutations are often introduced Some of these concerns are enumerated below: in the genome when the CRISPR-Cas9 technique is applied and these mutations i. There is fear that permitting germ line can be passed from one generation to the gene editing would lead to the creation other. Concerns about adverse irreversible of offspring having some preferred traits. changes in the human gene pool are valid. Parents who want specific traits in their However, such concerns may also hinder children such as a specific hair or eye color, any efforts made towards developing height, memory, intelligence, would opt therapies that use gene editing technology for such genetic modification in order for changes that cannot be inherited, such to get the desired baby. This may lead to as developing a cure for cancer. a division in society where genetically modified humans are healthier and iv. Legalization of designer babies also raises conform better to societal standards of questions with respect to the degree of beauty than non-genetically modified parental intervention acceptable when humans. Germ line gene editing can changing the appearance of the fetus. also make upward social and economic Currently, parents exert limited control mobility for persons from disadvantaged over the appearance and personality communities more difficult as such of their child. A child’s personality persons will not have been genetically is impacted not only by her home modified to be more intelligent and environment but also through her lived attractive as compared to their richer peers. experiences outside the home. Allowing Another issue with germ line gene editing parents to pick traits for their child before is a possible widening of the health gap such child is born diminishes the influence between rich and poor, both within of other factors. For instance, behavioral a society and between nations.26 traits such as obedience, laziness or a tendency to procrastinate are partially ii. A distinction must be made between inherited and partially learnt. Through treating a person that already exists gene editing, parents can ensure that their versus genetically modifying an embryo.27 child is obedient and less likely to question Modifying the genetic make-up of an already authority thereby eliminating the nurture existing person is more likely to be seen as portion of nature versus nurture. Some treatment, especially in cases where such parents may focus more on making sure individual is unlikely to reproduce. Any their child is beautiful while others may genetic changes in the individual will come choose to make their child more intelligent to an end with the death of such individual. or more musical. Parents can even make iii. Another concern that has been raised sure their child has a small appetite. In by many scientists is that since genome either case, the child has no control over editing in human embryos could have the traits it will ultimately possess. For unpredictable effects on future generations, the child the degree of their intelligence or attractiveness is decided either by fate or by their parents. Neither is objectively 26. Philip Ball, Designer babies: an ethical horror waiting to happen? https://www.theguardian.com/science/2017/jan/08/design- fairer than the other. Additionally, as er-babies-ethical-horror-waiting-to-happen (last accessed on discussed above, parents do exert a good Sep. 8, 2018) deal of influence on their children in status 27. Supra note 4, at 3

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Analysis of law, policy and ethics surrounding germline genetic engineering

quo. Parents make decisions with respect set of lawsuits. In 2014, a court in England to what city the child will be brought up held that the mother of a child born with in, what school the child will attend, who fetal alcohol spectrum syndrome due the the child interacts with when growing up, mother’s heavy drinking during pregnancy and even what the child eats. Allowing is not guilty of causing harm to the child. If parents to pick physical or character traits designer babies become a reality, we may is not much of a leap from letting parents see many more lawsuits with children pick their child’s name, an indicator of her suing their parents for the decisions made identity for her entire life. Gene editing when the child was in the womb. fetuses could also lead to an interesting

6. Intellectual Property Right Issue

The potential creation of a designer baby brings The European Union, in Directive 98/44/ forth a multitude of intellectual property right EC of the European Parliament and of the issues. The first issue is whether a human gene Council of 6 July 1998 on the legal protection is patentable. A gene patent is the exclusive of biotechnological inventions (“Directive”), rights to a specific sequence of DNA (a gene) provides that the mere discovery of a sequence given by a government to the individual, or partial sequence of a human gene cannot be organization, or corporation who claims to patented. However, an element isolated from the have first identified the gene. Once granted human body or produced by means of a technical a gene patent, the holder of the patent dictates process, including the sequence of a gene, may how the gene can be used, in both commercial constitute a patentable invention, even if the settings, such as clinical genetic testing, and in structure of that element is identical to that of noncommercial settings, including research.28 a natural element.30 Thus, isolation of gene is patentable in Europe, where as in the USA it is The Supreme Court of the US (“SCOTUS”) not. Further, the European Union, under the has laid down that human genes cannot be Directive explicitly prohibits the patentability the subject matter of a patent. In Association of processes for modifying the germ line genetic for Molecular Pathology v. Myriad Genetics29 identity of human as well as the use of human SCOTUS was required to decide whether a embryos for industrial or commercial purposes.31 naturally occurring segment of DNA- gene, by This was implemented, in particular, to respect its isolation from rest of the human genome the physical integrity of descendants.32 This is patentable. This would grant an exclusive provision gives concrete form to the concepts of right to the patentee (Myriad) to further study, ordre public and morality.33 manipulate or use that particular gene. The Court held that the location and order of the In India, to be patentable, a product or a process gene existed in nature before the patentee must be novel, involve an inventive step and be discovered the gene. Therefore, the patentee capable of industrial application.34 Discovery35 did not alter or create the genetic structure. The by itself will not merit a patent. Therefore, only contribution was uncovering the precise mere discovery of a gene which is naturally location and genetic sequence of the gene in occurring in nature will not amount to an question. The court emphatically laid down that invention and is not patentable. Further, the nothing new is created when discovering a gene, Guidelines for Examination of Biotechnology as it is a product of nature. Consequently, there is Applications for Patent, 2013 (“GEBAP”) state no intellectual property to protect through that sequences isolated directly from nature are a grant of patent. A human gene is not eligible for not patentable.36 a patent merely because it has been isolated. The Court distinguished DNA that naturally occurs in humans from DNA, which is manipulated in 30. Article 5 of Directive a laboratory, like synthetic DNA (complementary 31. Rule 23d of European Patent Convention Regulations; Dr. Franz Zimmer, New Rules of the European Patent Office for DNA). Synthetic DNA can be patented because Biotechnological Inventions, https://grunecker.de/fileadmin/ it is not naturally occurring. The Court further Gruenecker/Informationen/Veroeffentlichungen/biorules. pdf (last accessed on Jan. 19, 2019) explicitly refused to pass judgement on scientific 32. Report from the Commission to the European Parliament and the alteration of the genetic code. Council - Development and implications of patent law in the field of biotechnology and genetic engineering, https://eur-lex.europa.eu/ LexUriServ/LexUriServ.do?uri=CELEX:52002DC0545:EN:HTML 28. Genetics Home Reference, Can genes be patented?, available 33. Supra note 38, at 17 at https://ghr.nlm.nih.gov/primer/testing/genepatents (last 34. Section 2(1)(j) of PA accessed on Jan. 23, 2019) 35. Section 3 (c) of PA 29. Association for Molecular Pathology v. Myriad Genetics 569 U.S. 576 (2013) 36. Part 11 of GEBAP

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While genes or sequences naturally occurring novelty, inventive step and industrial application, in nature are not patentable, a human gene it will still be ineligible for a product patent in sufficiently altered or modified, showing a degree view of the restriction given under the Guidelines of inventive advancement, non-obvious to a prohibiting the use of such gene after 14 days. person skilled in the art, as well as capable of Further, an invention the primary or intended industrial application may merit a product patent. use or commercial exploitation of which could It is vital to remember that under the Guidelines, be contrary public order or morality or which as explained previously, genome modification is causes serious prejudice to human, animal or restricted only to in vitro studies and a genome plant life or health or to the environment is also modified human embryo cannot be cultured not patentable.37 Under the premise that the beyond 14 days of fertilization or formation germline gene modification is unethical and may of primitive streak, whichever is earlier, thus lead to moral disturbances in the public sphere, eliminating all scope for the commercial or it may not be accepted as an invention and industrial use of such modified gene. As a result, therefore, not be patentable. even if altering a gene fulfils the criteria for

37. Section 3(b) of PA

7. Limitations and Challenges in India

In India, the limitations to creating a designer Moreover, the Delhi High Court in the case of baby are many fold, the Guidelines being the Roche Products India Pvt Ltd v Drugs Controller primary obstacle. The Guidelines prohibit even General of India40 made an important observa- research into human germ-line gene therapy. tion with respect to binding nature of guidelines It further categorically prohibits research issued by governmental agencies stating that involving implantation of human embryos “54. As regard binding nature of the guidelines, (generated by any means) after in vitro it is well settled principle of law that the guidelines manipulation, at any stage of development, are in the nature of the directions issued by the into uterus in humans. However, the million government and till the time the said guidelines dollar question to be answered is whether the and directions are not in contradiction but are guidelines have the force of law? mere addition to the already existing rules While the Guidelines have not been issued and regulations, it cannot be said that the said under any law or have been ratified by India’s guidelines are not having legal validity and legislature, they are still sanctions attached to are not required to be adhered to being non disobeying the Guidelines. binding in character. Medical practitioners are governed by a code 58….it is clear that the administrative orders, of conduct. In India, the code of conduct directions or guidelines do not create any applicable to registered medical practitioners justiciable right is a rule not without exception is called Indian Medical Council (Professional and in the cases where the guidelines are framed conduct, Etiquette and Ethics) Regulations, 2002 with aim to fill the gaps in the legal framework (“MCI Code”). The MCI Code provides that or regulatory measures or are supplemental rules, research involving patients or volunteers can the courts can proceed to enforce them in the form be undertaken, provided ethical considerations of legally justiciable right in such circumstances.” are borne in mind. Violation of existing ICMR In our assessment, the Guidelines do not have guidelines (such as the Guidelines) amounts the force of law because there is no direct penalty to professional misconduct.38 If the medical associated with breach of the Guidelines. If, practitioner is found to be guilty of committing however, a professional association is of the professional misconduct, then the name of such opinion that it is unethical to intentionally breach practitioner may be removed from the register the Guidelines, and that such breach amounts maintained by the Medical Council of India and/ to professional misconduct of a degree that or State Medical Councils,39 meaning that such action should be taken against erring individuals, medical practitioner will not be able to practice then the Guidelines may find force through medicine in India. Since non-compliance with a coercive order of the professional association. the Guidelines is deemed to be unethical; it is The observation of the Hon’ble High Court quoted quite likely that doctors involved in any research above were issued in context of a guideline that involving genetic editing for creation of designer was to enforce an existing law. Therefore, the babies may lose his/her license to practice. observation should not be read in isolation. Therefore, the Guidelines may be enforced indirectly through other legal instruments that apply to professionals, such as the MCI Code.

38. Clause 7.22 of CMER

1439. Clause 8.2 of CMER 40.© Nishith 2016 Desai(66) PTC349 Associates (Del) 2019 Are we ready for Designer Babies?

Analysis of law, policy and ethics surrounding germline genetic engineering 8. The Present and Future of Designer Babies in India – A Clarion Call for Change

At the moment, it is clear that any research squarely to the science of germ line gene editing. effort put towards creation of Designer Babies The criticisms against creation of designer babies in India would be considered unethical on are not so much against the science itself, as they account of ICMR Guidelines. It is not, however, are against our inability to resist our urge illegal because the ICMR Guidelines are not to misuse the science. backed by a legislation. Having said that, We believe that the science presents real while the enforceability of ICMR Guidelines opportunities to push human race on the whole can be questioned, the position of the Indian towards a disease free and healthier tomorrow. Government on Designer Babies cannot be. The The science is not meant to regulate humans, ICMR guidelines make it very clear - India does for that we have the instrument of law for not support creation of Designer Babies, period. that. Therefore, India should work towards It has been famously said that science has the a legislation that regulates research into, and potential to change humanity, if humanity application of the research for creation of wishes to be changed. These words apply Designer Babies.

9. Designing the Law on Designer Babies

A blue-print of the proposed legislation in India: representation from the scientific community, the society, NGOs and the 1. To begin with, the legislation can control government itself. the laboratories where such research can take place. The legislation can specify that 3. A central registry can be maintained by research on germ line gene editing with the researchers who are working on the science. intention of creating designer babies must The registry should be regularly updated only take place in laboratories controlled with the information of the scientific by the government, or laboratories community at large to know what that have supervision of a government research is on-going and what are the appointed ethics committee. That way, the results of such research.

government will be able to check unethical 4. Any research or its application outside application of the science. the purview of legislation can be made 2. The application of the science to humans a cognizable, non-bailable criminal offence, i.e. implanting a fetus with edited germline treating such experiment on lines of harm so that it can grow into a healthier baby, done to the body of a human being. may be regulated by requiring approval We hope that such a legislation based on the above of a central body appointed by the blue print takes birth and sees the light of the day, government before such an implant before the science behind it dies a lonely death. can take place. This body can have

Analysis of law, policy and ethics surrounding germline genetic engineering 10. Conclusion

“Genetic engineering is a result of science stages, and genetic engineering appears to be no advancement, so I don’t think that in itself is exception. Unfortunately, the often quoted bad. If used wisely, genetics can be beneficial, but ‘dice’ appears to be loaded against the science. they can be abused, too. – Hideo Kojima” The use of the technique in China on fetuses without supervision has brought negative It is very clear that there is tremendous potential media coverage and cast doubts on funding/ to germline gene editing and its application in support of ethical and controlled experiments. improving the human race. At the same time, it If this science is not allowed to live, it will die an is also very clear that it is a very sensitive subject untimely death. A science that can in fact make and needs to be approached with caution. difference of life and death, deserves more than Like with any major technological break- a second chance. through, the technology and its application is We strongly believe that the science of germline bound to be doubted. The biggest opposition gene editing will be the key that will unlock to the technology, which can crudely be a more glorious future for the human race. In summarized as “playing god”, appears to be India, at least, the present circumstances are not a perception issue which can be overcome conducive for germline gene editing, but the by showcasing positive results. The benefits same could change with some innovative legal of science have always been doubted at early and policy ‘designing’.

Our expertise in Pharmaceutical and Healthcare

I. Introduction

At Nishith Desai Associates (NDA), Dr. Milind Antani, a successful surgeon turned lawyer leads the team that has represented various Pharma and Healthcare companies on regulatory issues as well as on transactions that have included PE and VC investments, M&A, Joint Ventures, Co-development, Multi-level collaborations and IP driven deals. The team has advised many companies on regulatory compliances allied to licensing and approvals, clinical trials, product promotions, advertisements, anti- corruption practices, ethical issues, MCI ethical guidelines, pricing related issues, FDI related concerns etc. NDA’s ongoing endeavors in conducting and facilitating original research in emerging areas of law, especially when it comes to Pharma and Healthcare, has helped our team to develop unparalleled proficiency to anticipate legal obstacles, mitigate potential risks and identify new opportunities for our clients on a global scale. Simply put, for conglomerates looking to conduct business in the subcontinent, NDA takes the uncertainty out of new frontiers. Supported by a team of legal experts with unparalleled domain knowledge, the team brings with it not just legal proficiency but an acute understanding of the economics of the business led by key industry insights substantiated by his vast experience in the field. However, the most important benchmark to us for our services will always be client satisfaction. Ranked at the coveted No.1 spot for ‘Client Satisfaction’ by RSG – Financial Times’ in 2016, here is a glimpse into what our clients have to say about us: “We are very happy with their work and the solutions they provide. They are very quick, very accurate and very solutions-driven.” “They are responsive, reliable and seem to be well connected. We are comfortable with their advice and I would recommend them.” Clients enthuse: “He (Dr.Antani) is fantastic. He has specialized knowledge and understands the techniques and science behind our products. It’s easy to get advice from him without having to explain the science.”

II. Services

A. Strategy Our team holds forth on proving expert opinion to business entities in the pharmaceutical and healthcare at every phase of their growth cycle, including - formation, early stage financing, technology and licensing, research and development, intellectual property portfolios, initial public offerings and follow-on securities offerings, protection and litigation of intellectual property, development and financing of manufacturing facilities as well tax structuring. The firm is especially well-equipped to service the legal and tax complexities attendant to multinational clients setting up operations in India. The firm also represents life science and healthcare clients across a wide range of services including the drafting and negotiation of research and collaboration agreements, intellectual property protection and litigation and numerous public finance, Joint Venture, M&A, private equity and venture capital transactions.

Analysis of law, policy and ethics surrounding germline genetic engineering

B. Regulatory Issues We advise on various regulatory issues and compliances related to promotion, marketing, advertisement, pricing, HCP interaction, labelling, clinical trials, research and development, manufacturing, import & distribution. We also counsel pharmaceutical and healthcare companies on regulations related to collaborative activities in India such as joint ventures and partnerships.

C. Documentation and Advisory Services The team’s expertise is well established when it comes to providing strategic guidance on structuring, drafting and negotiation of various contracts including contract manufacturing agreements, contract research, service agreements, marketing and distribution agreements, outsourcing agreements, IP assignment and license agreements. Clinical trial agreements, master service agreement, nondisclosure agreement, sponsored research agreement, material transfer agreement and confidentiality disclosure agreements, informed consent forms and other relevant documents.

D. Investments Our knowledge and proficiency, when it comes to the pharmaceutical industry in India as well as globally, has been the main stimulus in the growth of our funds and private equity practice. We guide overseas private equity investors and venture capital funds on their investments in the pharmaceutical and healthcare industry through Term sheet, Due Diligence, Documentation and Negotiations.

E. Corporate Transactions Our team provides advice and assistance across various corporate transactions, including Mergers & Acquisitions, Joint Ventures and various collaborations related to the licensing for drug developments in the pharmaceutical, biotechnology and healthcare sectors.

F. IP Advisory We assist in the drafting, filing and prosecution of intellectual property applications. We routinely handle the drafting of complex patent specifications for a wide array of technologies in addition to filing domestic, PCT and National Phase patent applications and assisting in the filing of foreign patent applications and freedom to operate opinions. We assist clients in identifying their intellectual property in order to formulate comprehensive strategies to help clients protect and leverage such intellectual property. We also assist companies managing patent compliance, patent landscape study as well as trademark portfolio management with uniquely designed software. Our life science team also assists clients in conducting detailed IP audit of the portfolio of a company.

G. Patent Litigation We have an extensive litigation practice that focuses on the protection of patents and other intellectual property. As mentioned earlier, the presence of a surgeon, chemical and biomedical engineers, Indian patent agents and a U.S. Patent Attorney helps us to understand the underlying science and technology at great speed and provide focused solutions.

H. Funds Our funds team is well equipped with the expertise of structuring and positioning life sciences funds in India. We guide our clients in order to maximize investment decisions in addition to servicing them in all aspects of tax and legal issues that arise when delving into venture investments in India.

I. Due Diligence We are able to undertake comprehensive legal and regulatory due-diligence of pharmaceutical and healthcare businesses with the help of our industry insights. Our expertise in the pharma and life sciences sector enables us to identify critical issues that a financial or strategic investor in pharmaceutical and healthcare companies should carefully understand and address.

J. Structuring We routinely advice on structuring transactions from a tax, legal and regulatory perspective. On the tax structuring side, we advise and determine tax favorable jurisdictions for investment purposes, permanent establishment, and transfer pricing instruments. We also facilitate the establishment of business in India, including the incorporation of companies and logistical operations of setting up branches and liaison offices in India. We have and continue to advise several new life sciences clients on their India-related operational activities.

K. Litigation Our team assists and advices on pre-litigation strategies with respect to the current IP and regulatory landscape in India. We have represented international and domestic clients in IP litigation and alternate dispute resolution. We have extensive experience representing clients at every level of the judicial system and virtually all disputes, from relatively simple matters to highly complex cases in product liability, patent infringement, antitrust and securities.

L. Training We conduct workshops for employees of pharma and healthcare companies on Indian legal and regulatory compliance requirements encapsulating the current pharma, life sciences and IP landscape at national and international seminars.

The following research papers and much more are available on our Knowledge Site: www.nishithdesai.com

Private Equity International Are we ready for MUM B A I SILICON VALLEY BANGALOR E SINGAPOR E M UMBAI BKC NEW DELHI MUNICH N E W Y ORK and Private Debt MUM B A I SILICON VALLEY BANGALOR E SINGAPOR E M UMBAI BKC N E W D E L H I M UNICH N E W Y ORK Commercial Designer Babies? Investments in Arbitration: Private Equity International and Private Debt India Commercial Law and Recent Investments in India Arbitration Strategic, Legal, Tax and Ethical issues Developments in Law and Recent May 2019 Developments in India India May 2019

Dispute Resolution The Indian Medical Impact MU M B A I SILICON VALLEY BANGALOR E SINGAPORE MUMBAI BKC NEW DELHI MUNICH N E W Y ORK in India: An MU M B A I SILICON VALLEY BANGALOR E SINGAPOR E M U M B A I B K C NEW DELHI MUNICH N E W Y ORK Device Industry: MU M B A I SILICON VALLEY BANGALOR E SINGAPORE MUMBAI BKC NEW DELHI MUNICH N E W Y ORK Investment: Introduction Regulatory, Legal Innovation for Dispute Resolution The Indian Medical Impact Investment: in India Device Industry and Tax Innovation for India’s India’s Education Regulatory, Legal and Education Sector An Introduction Tax Overview Only for Private Circulation Sector April 2019 Strategic, Legal, Tax and Ethical issues Strategic, Legal and Tax Issues

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IP Centric Deals: Fund Formation: Building a MU M B A I SILICON VALLEY BANGALOR E SINGAPORE MUMBAI BKC NEW DELHI MUNICH N E W Y ORK Key legal, tax MU M B A I SILICON VALLEY BANGALOR E SINGAPOR E M U M B A I B K C NEW DELHI MUNICH N E W Y ORK Attracting Global Successful and structuring Investors Blockchain Fund Formation: Building a Successful IP Centric Deals considerations Attracting Global Blockchain Ecosystem Ecosystem for Key legal, tax and structuring Investors for India considerations from Indian law perspective from Indian law Global, Regulatory and Tax Regulatory Approaches to India Environment impacting Crypto-Assets India focused funds February 2019 An independent submission to the perspective Government of India February 2019 December 2018

Nishith M. Desai Vaibhav Parikh Jaideep Reddy

NDA Insights

TITLE TYPE DATE Medical Device Wrap – 2018: Looking back to Look Beyond Pharma April 2019 Key developments of 2018 that will shape 2019 and beyond Pharma March 2019 Patented new drugs and orphan drugs out of price control in India Pharma January 2019 Online sale of prescription medicines in jeopardy Pharma November 2018 DISHA: The first step towards securing patient health data in India Pharma July 2018 Bombay High Court Quashes 197 Order Rejecting Mauritius Tax Tax May 2019 Treaty Benefits Payments For Online Subscription Services Not To Be Taxed As Tax May 2019 Royalty Taxation Of Unexplained Cash Credits: Recent Developments Tax May 2019 Taxing Cross-Border Production Activities – Contract Language Tax May 2019 Re-Emphasized Delhi High Court Sets Aside The Arbitral Award Passed In The Dispute Resolution May 2019 Airport Metro Express Dispute Arbitration Clause In An Unstamped Agreement? Supreme Court Dispute Resolution May 2019 Lays Down The Law English Court’s Dictum On The “Without Prejudice” Rule Dispute Resolution May 2019 Bombay High Court Settles Dust Over Validity Of ‘Options’ Under Dispute Resolution May 2019 Securities Law

Analysis of law, policy and ethics surrounding germline genetic engineering Research @ NDA

Research is the DNA of NDA. In early 1980s, our firm emerged from an extensive, and then pioneering, research by Nishith M. Desai on the taxation of cross-border transactions. The research book written by him provided the foundation for our international tax practice. Since then, we have relied upon research to be the cornerstone of our practice development. Today, research is fully ingrained in the firm’s culture. Our dedication to research has been instrumental in creating thought leadership in various areas of law and public policy. Through research, we develop intellectual capital and leverage it actively for both our clients and the development of our associates. We use research to discover new thinking, approaches, skills and reflections on jurisprudence, and ultimately deliver superior value to our clients. Over time, we have embedded a culture and built processes of learning through research that give us a robust edge in providing best quality advices and services to our clients, to our fraternity and to the community at large. Every member of the firm is required to participate in research activities. The seeds of research are typically sown in hour-long continuing education sessions conducted every day as the first thing in the morning. Free interactions in these sessions help associates identify new legal, regulatory, technological and business trends that require intellectual investigation from the legal and tax perspectives. Then, one or few associates take up an emerging trend or issue under the guidance of seniors and put it through our “Anticipate-Prepare-Deliver” research model. As the first step, they would conduct a capsule research, which involves a quick analysis of readily available secondary data. Often such basic research provides valuable insights and creates broader understanding of the issue for the involved associates, who in turn would disseminate it to other associates through tacit and explicit knowledge exchange processes. For us, knowledge sharing is as important an attribute as knowledge acquisition. When the issue requires further investigation, we develop an extensive research paper. Often we collect our own primary data when we feel the issue demands going deep to the root or when we find gaps in secondary data. In some cases, we have even taken up multi-year research projects to investigate every aspect of the topic and build unparallel mastery. Our TMT practice, IP practice, Pharma & Healthcare/Med-Tech and Medical Device, practice and energy sector practice have emerged from such projects. Research in essence graduates to Knowledge, and finally to Intellectual Property. Over the years, we have produced some outstanding research papers, articles, webinars and talks. Almost on daily basis, we analyze and offer our perspective on latest legal developments through our regular “Hotlines”, which go out to our clients and fraternity. These Hotlines provide immediate awareness and quick reference, and have been eagerly received. We also provide expanded commentary on issues through detailed articles for publication in newspapers and periodicals for dissemination to wider audience. Our Lab Reports dissect and analyze a published, distinctive legal transaction using multiple lenses and offer various perspectives, including some even overlooked by the executors of the transaction. We regularly write extensive research articles and disseminate them through our website. Our research has also contributed to public policy discourse, helped state and central governments in drafting statutes, and provided regulators with much needed comparative research for rule making. Our discourses on Taxation of eCommerce, Arbitration, and Direct Tax Code have been widely acknowledged. Although we invest heavily in terms of time and expenses in our research activities, we are happy to provide unlimited access to our research to our clients and the community for greater good. As we continue to grow through our research-based approach, we now have established an exclusive four-acre, state-of-the-art research center, just a 45-minute ferry ride from Mumbai but in the middle of verdant hills of reclusive Alibaug-Raigadh district. Imaginarium AliGunjan is a platform for creative thinking; an apolitical ecosystem that connects multi-disciplinary threads of ideas, innovation and imagination. Designed to inspire ‘blue sky’ thinking, research, exploration and synthesis, reflections and communication, it aims to bring in wholeness – that leads to answers to the biggest challenges of our time and beyond. It seeks to be a bridge that connects the futuristic advancements of diverse disciplines. It offers a space, both virtually and literally, for integration and synthesis of knowhow and innovation from various streams and serves as a dais to internationally renowned professionals to share their expertise and experience with our associates and select clients.

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